Pancreatitis Clinical Trial
Official title:
Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis
The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.
The combination mode of ESWL and ERCP is an established method of treatment of painful
obstructive calcified chronic pancreatitis. However, the investigators notice that patients
after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments
and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone
fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of
patient care, without improving the outcome of the pancreatic pain.
So the investigators design such a prospective and randomized controlled trial. People
diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the
MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random
numbers.
ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions
will be repeated if necessary, until stone fragmentation is obtained. Patients in the
endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL
group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.
Follow-up will consists of telephone interview1 after treatment and clinical examination
every 6 months thereafter. Data collected will include clinical presentation, ESWL,
endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6
months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical
examination.
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